Safety and Immunogenicity Study of Intramuscular CCS/C-adjuvanted Influenza Vaccine in Elderly

NCT00915187 | Completed Phase 2 DMC

• 1 other identifier: NX09-4
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

To examine the safety and immunogenicity of two formulation of liposomal adjuvant / delivery system (VaxiSomeTM=CCS-Cholesterol \[CCS/C\]), combined with commercial influenza vaccine in an elderly healthy population when given once intramuscularly (IM).

Conditions

Influenza

Keywords

Vaccination, influenza prevention

Outcome Measures

Primary Outcomes (1)

• Immunogenicity will be evaluated according to the CHMP criteria for evaluation of flu vaccines, i.e., Seroprotection, Geometric Mean Ratios, and Seroconversion rate

  Day 28 following vaccination

Secondary Outcomes (1)

• Immunogenicity will be evaluated according to the CHMP criteria for evaluation of flu vaccines, i.e., Seroprotection, Geometric Mean Ratios, and Seroconversion rate

  Day 90 following vaccination

Study Arms (2)

Control

ACTIVE COMPARATOR

Biological: Influenza Vaccine

CCS/C (Adjuvant Formulation)

EXPERIMENTAL

Drug: CCS/C

Interventions

CCS/C DRUG

Adjuvant to influenza vaccine

CCS/C (Adjuvant Formulation)

Influenza Vaccine BIOLOGICAL

Influenza vaccine

Control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• years of age or older, mentally competent, willing and able to give written informed consent prior to study entry, male or female;
• able to comply with all the study requirements;
• in stable good health as determined by medical history; physical examination; clinical judgment of the investigator.
• Have adequate renal function (renal clearance of at \> 30ml/min)
• Have normal liver function (hepatic transaminases \[ALT and AST\] \< 43 U/L)
• Have hemoglobin \> 11.5 g/L

You may not qualify if:

• Any serious chronic or acute disease (in the judgment of the investigator) including but not limited to: cancer, except for localized skin cancer;
• Advanced congestive heart failure; Acute exacerbation of Chronic obstructive pulmonary disease (COPD); Autoimmune disease, Acute or progressive hepatic disease; Acute or progressive renal disease with a renal clearance of at \< 30ml/min ; Severe neurological or psychiatric disorder; History of Guillain Barré syndrome; Severe asthma.
• Clinically significant symptoms of neurological disease; untreated hypertension; increased liver enzymes.
• History of any anaphylactic reaction and/or serious allergic reaction following a vaccination

Sponsors & Collaborators

• NasVax Ltd: lead

Study Sites (1)

Clinical Pharmacology Unit, Division of Medicine, Hadassah University Hospital

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Yoseph Caraco, MD

  Clinical Pharmacology Unit, Division of Medicine, Hadassah University Hospital Jerusalem, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2009
• First Posted: June 5, 2009
• Study Start: October 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: February 1, 2010
• Last Updated: October 19, 2011

Record last verified: 2011-10

Locations

IL (1)